ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM— 510(k) K951360
Substantially EquivalentBayer Corp.
FDA 510(k) clearance K951360 for ESTRADIOL ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC SYSTEM, Substantially Equivalent on 1995-05-02. Applicant: Bayer Corp.. Device class: 1.
Clearance details
- Applicant
- Bayer Corp.
- Product code
- Code CHP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1260
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tarrytown, NY, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.